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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO LONG ATTACHMENT ORTHOPEDIC STEREOTAXIC INSTRUMENT

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BLUE BELT TECHNOLOGIES NAVIO LONG ATTACHMENT ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number PFSR110006
Device Problems Connection Problem (2900); Unintended Movement (3026)
Patient Problems Injury (2348); Deformity/ Disfigurement (2360)
Event Date 06/23/2020
Event Type  Injury  
Event Description
It was reported that during an ukr procedure, the bur was not fully locked into the anspach (it was not noticed as the homing passed without issues). The femoral cut was not compromised. However, when it was switched to speed mode and started working on the tibia, the bur must have been pulled forward. Towards the end, when cleaning up the proximal tibia cut, the bur went deeper than the system thought. Fortunately, the cortical bone outside layer was not damaged and the tibia base plate still had enough coverage. However, the defect caused by the overburring had to be filled up with cement. The ball bearings inside the long attachment were damaged from burring without the bur fully locked. It was hard to take the bur out and it was almost impossible to put it back in. This caused a delay of less than 30 minutes.
 
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Brand NameNAVIO LONG ATTACHMENT
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth MN 55441
Manufacturer (Section G)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth MN 55441
Manufacturer Contact
rick confer
2828 liberty avenue
suite 100, PA 15222
4126833844
MDR Report Key10280900
MDR Text Key199060860
Report Number3010266064-2020-01665
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPFSR110006
Device Catalogue NumberPFSR110006
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/07/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 07/15/2020 Patient Sequence Number: 1
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